Pharmaceutical composition containing antibody against IL-5 and use thereof
Disclosed in the present application are a pharmaceutical composition containing an antibody against IL-5 and use thereof. In particular, disclosed in the present application is a pharmaceutical composition, which contains an IL-5 antibody or an antigen binding fragment thereof in a buffer solution. In addition, the pharmaceutical composition further contains a saccharide and a nonionic surfactant.
1 . A pharmaceutical composition, comprising:
(a) an anti-IL-5 antibody or an antigen-binding fragment thereof wherein, the anti-IL-5 antibody or the antigen-binding fragment thereof comprises a heavy chain variable region comprising HCDR1, HCDR2 and HCDR3 as shown in amino acid sequence SEQ ID NOs: 16, 17 and 18, respectively, and a light chain variable region comprising LCDR1, LCDR2 and LCDR3 as shown in amino acid sequence SEQ ID NOs: 19, 20 and 21, respectively;
(b) a buffer, wherein the buffer is acetic acid-sodium acetate or succinic acid-sodium succinate buffer, the pH of the buffer is 5.0 to 6.5, the concentration of the buffer is 10 mM to 40 mM;
(c) a surfactant, wherein the surfactant is polysorbate 80, the concentration of the polysorbate 80 is 0.1 mg/ml to 0.6 mg/ml;
(d) a stabilizer, wherein the stabilizer is sucrose, the concentration of the sucrose is 50 mg/ml to 80 mg/ml.
2 . The pharmaceutical composition according to claim 1 , wherein the pH of the buffer is 5.0 to 5.8.
3 . The pharmaceutical composition according to claim 1 , wherein the concentration of the buffer is 20 mM to 30 mM.
4 . The pharmaceutical composition according to claim 1 , wherein the concentration of the anti-IL-5 antibody or the antigen-binding fragment thereof is 1 mg/ml to 120 mg/ml.
5 . The pharmaceutical composition according to claim 1 , wherein the concentration of the polysorbate 80 is 0.2 mg/ml to 0.6 mg/ml.
6 . The pharmaceutical composition according to claim 1 , wherein the concentration of the sucrose is 70 mg/ml to 75 mg/ml.
7 . The pharmaceutical composition according to claim 1 , wherein the anti-IL-5 antibody comprises:
a heavy chain variable region as shown in any one of SEQ ID NOs: 49, 50 and 51 or having 95% sequence identity with any one of SEQ ID NOs: 49, 50 and 51; and
a light chain variable region as shown in any one of SEQ ID NOs: 46, 47 and 48 or having 95% sequence identity with any one of SEQ ID NOs: 46, 47 and 48.
8 . The pharmaceutical composition according to claim 1 , wherein the anti-IL-5 antibody comprises human antibody constant region(s).
9 . The pharmaceutical composition according to claim 8 , wherein the anti-IL-5 antibody comprises:
a heavy chain as shown in SEQ ID NO: 83 and a light chain as shown in SEQ ID NO: 84.
10 . A lyophilized formulation comprising the anti-IL-5 antibody or the antigen-binding fragment thereof, which is obtained by lyophilization of the pharmaceutical composition according to claim 1 ; the lyophilization comprises the steps of pre-freezing, primary drying and secondary drying, successively.
11 . A reconstituted solution comprising the anti-IL-5 antibody or the antigen-binding fragment thereof, wherein the reconstituted solution is obtained by reconstitution of the lyophilized formulation according to claim 10 .
12 . An article comprising a container, wherein the container comprises the pharmaceutical composition according to claim 1 .
13 . A method for treating IL-5 mediated disease, comprising administering a therapeutically effective amount of the pharmaceutical composition according to claim 1 to a subject in need thereof; wherein the IL-5 mediated disease is selected from the group consisting of asthma, chronic pneumonia, allergic rhinitis, allergic bronchopulmonary aspergillosis disease, eosinophilia, Churg-Strauss syndrome, atopic dermatitis, onchocerciasis dermatitis, intermittent angioedema, eosinophilic myalgia syndrome, eosinophilic gastroenteritis, worm infection, Hodgkin's disease, nasal polyps, Loeffler's syndrome, urticaria, hypereosinophilic bronchitis, nodular arteritis, sinusitis, eosinophilic esophagitis, allergic eosinophilic esophagitis, allergic conjunctivitis, onchocerciasis dermatitis, endometriosis and steroid-dependent eosinophilic bronchitis.
14 . The pharmaceutical composition according to claim 1 , wherein the pH of the buffer is about 5.5.
15 . The pharmaceutical composition according to claim 1 , wherein the concentration of the buffer is about 30 mM or about 32 mM.
16 . The pharmaceutical composition according to claim 1 , wherein the concentration of the anti-IL-5 antibody or the antigen-binding fragment thereof is 80 mg/ml to 120 mg/ml.
17 . The pharmaceutical composition according to claim 1 , wherein the concentration of the anti-IL-5 antibody or the antigen-binding fragment thereof is about 100 mg/ml.
18 . The pharmaceutical composition according to claim 1 , wherein the concentration of the polysorbate 80 is about 0.4 mg/ml or about 0.6 mg/ml.
19 . The pharmaceutical composition according to claim 1 , wherein the concentration of the sucrose is about 72 mg/ml.
20 . The pharmaceutical composition according to claim 8 , wherein the anti-IL-5 antibody comprises: a human antibody heavy chain constant region as shown in SEQ ID NO: 52 and a human antibody light chain constant region as shown in SEQ ID NO: 53.